MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	CQF7588
Medical Device Problem Codes	Deflation Problem (1149); Material Deformation (2976)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the device is pending.The investigation of the reported event is currently underway.(expiry date: 08/2022).
Event or Problem Description
It was reported that during an angioplasty procedure in the brachial artery, the pta balloon allegedly could not be fully deflated.It was further reported that a needle stick was used to percutaneously deflate the balloon.The balloon was removed from the patient and another device was used to complete the procedure.There were no further reported complications to the patient.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.A visual inspection found bunching to the outer catheter shaft.Therefore, the investigation is confirmed for the identified outer catheter shaft bunching.Due to the condition of the returned device, functional testing was unable to be performed.Therefore, the investigation is inconclusive for the reported deflation issue.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 08/2022).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during an angioplasty procedure in the brachial artery, the pta balloon allegedly could not be fully deflated.It was further reported that a needle stick was used to percutaneously deflate the balloon.The balloon was removed from the patient and another device was used to complete the procedure.There were no further reported complications to the patient.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9914190
• Report Number: 2020394-2020-02249
• Device Sequence Number: 19671573
• Product Code: LIT
• UDI-Device Identifier: 00801741060571
• UDI-Public: (01)00801741060571
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K120660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CQF7588
• Device Catalogue Number: CQF7588
• Device Lot Number: REDW1358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention